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            <h3>Integrated Solution for Pharmaceutical Development&Product Life Cycle Management</h3>
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                        <h3>Manufacturing Improvement</h3>
                        <div class="fontp">
                            <div>Monitor & track any changes made after product approval, internal and external, to ensure our customer’s product in compliance with most updated regulatory requirements all the time.</div>
                            <br> <span>Drug Establishment Registration & Change Control</span>
                            <br> <span>API/Drug Product Commercial Label Changes</span>
                            <br> <span>Impact Analysis on Changes made on approval product</span>
                            <br> <span>Product Improvement Study and Revalidation/Revarification</span>
                            <br> <span>Periodic Product Quality Management System Evaluation</span>
                            <br> <span>Product Quality Matrix Report/Annual Report Draft/Compilation/Submission</span>
                            <br> <span>Batch Size, Manufacturing Cost of Goods, and Manufacturing Capacity Evaluation</span>
                            <br> <span>Life Cycle Management of Submitted Documents</span>

                        </div>
                    </div>
                    <div>
                        <h3>Integrated Product Design Module</h3>
                        <div class="fontp">
                            <div>Conduct individualized based analysis on key product attributes and define overall regulatory strategy with customer at early stage to mitigate risks</div>
                            <br> <span>API/Formulation QTPP Design</span>
                            <br> <span>API/Formulation CQA Identification</span>
                            <br> <span>API Physical Property Characterization & Impact Study</span>
                            <br> <span>API Synthesis Route Determination & Impurity Profile Study</span>
                            <br> <span>Pre-formulation/De-formulation Studies</span>
                            <br> <span>Formulation & In Vitro Dissolution Method Development</span>
                            <br> <span>Preliminary Stability Study & Forced Degradation Studies</span>
                            <br> <span>Risk Assessment on Development Strategy & QoS Integration</span>
                        </div>
                    </div>
                    <div>
                        <h3>GMP Quality Management System</h3>
                        <div class="fontp">
                            <div>Tai Heng’s Quality System is established on our solid scientific knowledge and proven regulatory understanding.  Our quality management team work meaninglessly with the rest of Tai Heng staff to ensure our quality system is effectively & properly implemented, and GMP principle on authenticity, traceability, and reproducibility will never be compromised.</div>
                            <br><br> <span>Change Control System</span>
                            <br> <span>Investigation and CAPA System</span>
                            <br> <span>Fully Equipped QC Laboratory and CDS System</span>
                            <br> <span>GMP Document Management System</span>
                            <br> <span>Continuous Staff Training/Qualification</span>
                            <br> <span>Facility & Equipment Life Cycle Management System</span>
                            <br> <span>Supply Chain Audit & Periodic Quality Review</span>
                            <br> <span>Regulatory Evaluation and US FDA Inspection Mangement</span>

                        </div>
                    </div>
                    <div>
                        <h3>Product Registration/Submission</h3>
                        <div class="fontp">
                            <div>Assist Sponsor to define the most efficient regulatory strategy based upon existing development status and available information, and achieve best application outcome.</div>
                            <br> <span>International Regulatory Support (US FDA, Health Canada, EDQM etc.)</span>
                            <br> <span>Document Management for IND/NDA/ANDA/DMF/CEP</span>
                            <br> <span>Drug Establishment /Drug Product Registration</span>
                            <br> <span>CTD Document draft, compilation and review</span>
                            <br> <span>IND/NDA/ANDA/DMF/CEP Submission & Post Submission Management</span>
                            <br> <span>Deficiency response strategy.</span>
                            <br> <span>Domestic Regulatory Support</span>
                            <br> <span>Due Diligence Review on Import Registration</span>
                            <br> <span>Import Registration Submission and Management, including Translation</span>
                            <br> <span>Generic Drug Re-evaluation Submission & Management</span>

                        </div>
                    </div>
                    <div>
                        <h3>Manufacturing Process Optimization</h3>
                        <div class="fontp">
                            <div>Define and design Process Control Strategy, with sound analytical methods and sampling plan to ensure its efficiency, robustness, and productivity.</div>
                            <br> <span>Determine API/Formulation Critical Process Parameters</span>
                            <br> <span>DOE on Manufacturing Process</span>
                            <br> <span>QbD based Process Optimization</span>
                            <br> <span>Control Strategy development, including Sampling Plan & Analytical Methods</span>
                            <br> <span>Comparative Dissolution & Process Impact Studies</span>
                            <br> <span>ICH based Stability Studies & Packaging Configuration Studies</span>
                            <br> <span>Risk Assessment on Manufacturing Strategy & QoS Integration</span>

                        </div>
                    </div>
                    <div>
                        <h3>Scale Up & Tech Transfer</h3>
                        <div class="fontp">
                            <div>Conduct on-site audit and proper tech transfer, to ensure both engineering batch(es) & submission batch(es) are meeting the most stringent US FDA regulation and other compliance requirements.</div>
                            <br> <span>Manufacturing Site Audit and Risk Assessment</span>
                            <br> <span>GAP Analysis on Manufacturing Process and Analytical Testing Capacity/Capability</span>
                            <br> <span>Design Scale Up & Tech Transfer Protocol</span>
                            <br> <span>Design Cleaning Validation Strategy and Protocols</span>
                            <br> <span>Design Analytical Method Transfer Protocols</span>
                            <br> <span>Design Process Validation Protocols (API & Formulation)</span>
                            <br> <span>Design Pre-submission and Post Approval stability protocols</span>
                            <br> <span>Execute & Manage Engineering Batch Manufacture</span>
                            <br> <span>Batch Size, Manufacturing Cost of Goods, and Manufacturing Capacity Evaluation</span>
                            <br> <span>Scale Up/Tech Transfer Report & QoS Integration</span>

                        </div>
                    </div>
                </div>
            </div>
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